Tag Archives: Prior approval

In the second half of 2016, two very interesting decisions were issued by the federal courts in Brazil against the Brazilian Food and Drug Agency (ANVISA) involving the prior approval of patent applications claiming pharmaceutical products.These decisions bring some very good news to pharmaceutical patent owners who have struggled for years with ANVISA while trying to protect their pharmaceutical patents in this country.

In the decisions, Genentech and Novartis each obtained preliminary injunctions against ANVISA in cases of prior approval of their patent applications under Article 229-C of the Brazilian Patent Statute (Additional information about each of the decisions can be found here:novartisdecisiongenentechdecision).Specifically, Novartis’ patent application claims fingolimod (Gilenya) and Genentech’s application claims bevacizumab (Avastin).

Two different trial judges affirmed that ANVISA did not have the authority to examine patentability requirements under Article 229-C of the Patent Statute. In the decision involving Genentech’s application, the judge, the Honorable Diana Silva, limited ANVISA’s role during the prior approval process to only aspects involving public health. The decision also stated that the Brazilian Patent and Trademark Office, namely, the Instituto Nacional da Propriedade Industrial (INPI)is the sole legitimate agency to examine the patentability requirements of patent applications directed to pharmaceutical products.

The decision involving Novartis’ application is an important case for pharmaceutical companies facing the issues of backlog and pendency of their patent applications in Brazil. Specifically, in this case, Novartis sought a preliminary injunction against ANVISA, claiming that the agency was taking an unreasonable amount of time to issue a decision regarding prior approval.Additionally, Novartis also requested preventive measures against the agency to prevent it from examining the application for compliance with patentability requirements under the Brazilian Patent Statute (which is the function of INPI).The judge, the Honorable Iolete Oliveira, accepted Novartis’ arguments and granted a preliminary injunction ordering ANVISA to:(1) analyze the prior approval of the patent application within 15 days; and (2) abstain from examining the application for compliance with any patentability requirements but focus instead only on aspects of public health.

Both of these decisions highlight that the Brazilian federal courts are willing to limit ANVISA’s role under the prior approval analysis. The Novartis case establishes important precedent that can be used by other companies currently waiting ANVISA’s decision on prior approval analysis.